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Anthrax vaccine risks

Civilians who want the anthrax vaccine
but cant get access may be surprised that a growing coalition of concerned
citizens  mostly military  is decrying its use.

Many
objecting to the vaccine are military veterans who say they have been severely
injured by it. Others were court-martialed for refusing the inoculation.
Some say the inoculation is riskier than treating anthrax infection with
antibiotics.

The anthrax vaccine in use
remains unproven in its ability to stop a lethal dose of weaponized Bacillus
anthracis spores, and there are questions about its safety. According to the
U.S. Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort
Detrick, MD, the anthrax vaccine used by the military was determined to be safe,
and adverse reactions were found to occur only at the rate of one per 50,000
doses (less than 0.002%). This has now been revised to a rate of 0.02-0.2% or
higher. Moreover, in recent testimony by one of us [M.N.] to the National
Academy of Sciences the safety of the anthrax vaccine and the rates of adverse
reactions were questioned. Using Dover
AFB as an example, the rate of chronic health problems after receiving the
anthrax vaccine may be as high as 7%. The difference is that the official rates
are for acute reactions only. The Department of Defense (DoD) claims that the
rate for vaccine chronic reactions is zero.

A major part of the problem in assessing
vaccine safety is in how vaccine adverse effects are reported. Many
people who suffer from adverse anthrax vaccine effects are reluctant to step
forward to seek medical care, because they have seen their colleagues' concerns
dismissed as due to depression or stress. They also fear that they could lose
their ability to perform their duties, as a number of the pilots and airmen at
Dover AFB are now on DNIF (duties not including flying) status because of
undiagnosed illnesses that began after they received their anthrax vaccinations.
Lt. Colonel Randy Randolf, director of the U.S. Armys vaccination program,
counters that all vaccines, the anthrax vaccine included, can produce adverse
effects, such as soreness, redness, itching, swelling, and lumps at the
injection site. He has stated that about 30% of men and 60% of women report
these local reactions, but they usually last only a short time. Lt. Col. Randolf
further describes that beyond the injection site, from 5% up to 35% of people
have noticed muscle aches, joint aches, headaches, rash, chills, fever, nausea,
loss of appetite, malaise, or related symptoms. It is commonly thought that
these symptoms go away after a few days, and apparently
there has been no completed studies of long-term side effects of anthrax vaccine
using active surveillance. Although the DoD began such a study at Tripler
Army Medical Center, Honolulu in September, 1998, they have yet to release any
preliminary data on long-term problems that developed after anthrax vaccination.

The difference between what military and
civilian physicians conclude about adverse reactions and the anthrax vaccine
seems to be based on whether you accept that vaccines can cause chronic
illnesses beyond the initial reporting period of vaccine adverse effects. The
high incidence of unusual chronic health problems at Dover AFB include systemic
signs and symptoms, such as vomiting, diarrhea, polyarthralgias, fever, splenic
tenderness, cognitive problems, polymyalgias, weakness and numbness, and these
problems can occur well after the usual reporting period for vaccine adverse
effects. Patients with preexisting autoimmune illnesses such as rheumatoid
arthritis, lupus, multiple sclerosis, among others, are probably more likely to
suffer a serious adverse reaction, as are those with neurologic disease, such as
those who had polio in childhood. Stevens Johnson Syndrome, a severe allergic
reaction in which there is loss of epidermis (skin) and the lining of the GI
tract, was found in some patients as well as more classic allergic signs and
symptoms. Even more serious, many anthrax vaccine recipients report seizures
with complete loss of consciousness. Respiratory distress and a variety of
pulmonary illnesses have also been reported. Because these types of
reactions have rarely been identified with other vaccines and because few of
those reporting illness have been subjected to an exhaustive medical evaluation,
including sophisticated immunological testing, the mechanisms by which anthrax
vaccine may be causing illnesses have not been elucidated. Furthermore, the
entire stockpile of anthrax vaccine is owned by the DoD, and none has yet been
made available for thorough, independent testing.

The Anthrax
Vaccine: Source
One of the most difficult problems in dealing with anthrax vaccine safety is
obtaining specific information on the anthrax vaccine and how it was determined
to be safe. Most military vaccines in the U.S. are from sole-source
manufacturers. In the case of FDA-approved vaccines, a number of strict
production and safety requirements must be fulfilled, and evidence for
effectiveness in humans must be presented to the FDA before approval for
production and sale is granted. However, in the case of the anthrax vaccine
there seem to be missing elements in this safety net.

The sole producer of the anthrax vaccine was originally Michigan Biologic
Products, Inc., a state-owned corporation that obtained U.S. Government approval
for the anthrax vaccine at a time when FDA approval was not required. The
anthrax vaccine was approved by the Bureau of Biologics at NIH in 1970, two
years before efficacy data and approval were required by the FDA. In the case of
the anthrax vaccine, long-term safety data were not supplied with the license
application, and none has yet been supplied to the FDA. As it turns out, the
Bacillus anthracis vaccine now being produced may be different or the procedure
for vaccine preparation modified from the original vaccine approved by NIH. The
usual requirement is that any new product or modification in preparation must be
examined and approved by the FDA, but the FDA has apparently not examined or
approved every modification made to the current vaccine for anthrax.

The original license and the facility producing the anthrax vaccine was owned by
Michigan Biologic Products, Inc. of the Michigan State Department of Health. The
new owner of both is a company called Bioport, Inc., owned by a group of
investors lead by Admiral William Crowe, Jr., former head of the Joint Chiefs of
Staff, DoD, and Faud El-Hibri, a German citizen of Lebanese descent who has
since obtained American citizenship. The facility was sold to Admiral Crowes
investor group after the DoD decided to vaccinate all of its servicemen and
servicewomen against anthrax. Recently Bioport ran into financial problems and
negotiated a series of changes in its DoD contract that increases by three-fold
the per dose price of the anthrax vaccine supplied to the military. This and
other problems have resulted in a congressional investigation into the financial
relationship between DoD and the new owners of Bioport, which may constitute a
conflict of interest.

A study of Kansas Gulf War
veterans was published in 2000 (4). This study also found that deployment
vaccines were related to GWS: 34% of Gulf War veterans met the
definition for GWS, while only 4% of
non-deployed, non-vaccinated Gulf-era veterans met the definition. However,
12% of Kansas Gulf-era veterans who were vaccinated in preparation for
deployment, but then were not sent to the Gulf, also met the GWS
definition. The paper concluded, "Vaccines used during the war may be a
contributing factor."

Amid pressure to vaccinate civilians at risk for
anthrax, evidence has emerged that unauthorized
changes in the vaccine manufacturing process before the Gulf War may have
radically boosted the potency of the controversial shots.

Veterans groups and armed services personnel
have complained that the anthrax vaccine is unsafe, and they say the new
evidence lends credence to their view.

Researchers at the Army's biological warfare
defense lab found as much as a 100-fold
increase in the concentration of the anthrax vaccine's active ingredient
in batches produced after a switch to new filters in 1990.

According to the lawsuit, Larson began
receiving her six injections in late 1998 and "almost
immediately ... began having adverse reactions to the vaccine, including
exhaustion and fatigue, skin rashes and numbness and pain in her hands."

When these symptoms did not dissipate,
she was admitted to a military hospital, where she later
lapsed into a coma and died, the complaint said.

Wilson, a helicopter pilot, also began
having adverse reactions "almost
immediately" after receiving her inoculations in late 1998, including rapid
weight loss and an inability to eat solid foods, the lawsuit
alleged.

Thomas J. Colosimo joined the Air Force nearly
11 years ago dreaming of seeing the world and building a strong future for
himself. Now, he wonders if he has a future at all.

After taking the anthrax vaccine, Tom
Colosimos health  and spirit  quickly started to deteriorate.

Still just 29 years old, his once-powerful
physique is so withered and frail he must walk with a cane. His boyish looks are
marred by bruises and scars, the result of the falls he takes when he
unexpectedly passes out. Its gotten so bad hes resorted to wearing a
hockey helmet around the house.

Life for Colosimo consists of sitting and
eating. He sleeps poorly, lives in dread of moments when he slips into delirium,
he stumbles over words, his body fails him daily. He has become, he says, a
prisoner in his own body.

But unlike sufferers of the mysterious Gulf War
illness, whose doctors cant pinpoint a specific cause for their maladies,
Colosimo has medical problems linked to the anthrax vaccine, as publicly
acknowledged by Marine Corps Maj. Gen. Randy West, senior adviser to the deputy
secretary of defense for chemical and biological protection.

The
illness known as Gulf war syndrome looks likely to have been caused by an
illegal vaccine "booster" given by the Ministry of Defence to protect
soldiers against biological weapons, according to the results of a new series of
tests.

Scientists
in the United States found that symptoms of the illness were the same for
service personnel who received the injections whether or not they served in the
Gulf.

The
common factor for the 275,000 British and US veterans who are ill appears to be
a substance called squalene, allegedly used in injections to add to their
potency. Such an action would have been illegal. Squalene is not licensed for
use on either side of the Atlantic because of potential side effects.

A list of questions along with a cover
letter was sent to the home addresses of 265 squadron members, according to the
survey authors. The only members excluded were the administrative workers who
had not yet been vaccinated.

Of the 265
surveys sent out, 139 (55 per cent) were returned. The subjects were asked: "From
the time you received your first anthrax vaccination, have you started to
experience any of the following symptoms?" The numbers following the
symptoms are affirmative responses.

The company that makes the
anthrax vaccine says it could protect you from death, from getting the inhaled,
fatal form of the anthrax disease. However, WGN uncovered information that shows
the vaccine is not without problems.

A woman and her fellow servicemen, who
received the vaccine, say they are now living a soldier's nightmare.

"When the joint pain is acting up severely and also the migraines where you
just go sit in a dark room and cry," says Robin Hawes.

Three strong, healthy Michigan Air National Guard members who volunteered for
duty in the Persian Gulf never made it overseas.

"Imagine having the flu the worst that you could have it and that visits
you every week," says Tom Starkweather.

"I felt really fatigued, I was in bed constantly. I couldn't get up. I was
tired all the time," says David Churchhill.

Shortly after receiving four of the six required anthrax vaccine shots in 1998
and 1999, the military confirms, nine out of 12 members of the 110th Air Fighter
Wing got sick.

"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."

-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820

“A sacred cow will not protect the herd.”

-- Sandy Gottstein

"What's the point of vaccination if it doesn't protect you from the unvaccinated?"

-- Sandy Gottstein

"Who gets to decide what the greater good is and how many will be sacrificed to it?"